Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood

Launched by WELLSPECT HEALTHCARE · Nov 30, 2010

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provision of informed consent.
• • Male and female subjects aged 18 years and over subjected to spinal surgery with an approximate expected bleeding of 800-1500 ml.
• • Subjects classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology.
• Exclusion Criteria:
• • Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site).
• • Previous enrolment or randomisation of treatment in the present study.
• • Participation in another clinical study, that may interfere with the present study.
• • Severe non-compliance to protocol as judged by the investigator and/or Astra Tech.
• • Haemophilia.
• • Hyperkalemia (i.e. values above the normal reference values at study site).
• • Symptoms of impaired renal function including creatinine clearance levels (using the Cockcroft-Gault formula) \<30 ml/min.
• • Malignancy in the area of the operative site.
• • Current or expected use of cytotoxic drugs.
• • Symptoms of systemic infection or local infection in the operation field.
• • Pregnancy.
• • Sickle cell anaemia and/or pre-operative Hb concentration \<11 g/dl (6,8 mmol/l).
• • Use of recombinant erythropoietin (EPO) or fibrin sealant.
• • Use of other autologous blood transfusion than with the Sangvia® system (e.g. CellSaver and pre-donation) or other blood saving techniques (e.g. normovolemic hemodilution).
• • Hypotensive anesthesia.
• • Use of antithrombotic medication within 5 days of surgery (NSAID, Clopidogrel).